Anna E. Email & Phone Number

Cork, County Cork, Ireland

Cork, Ireland

Initiation investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, communication with ERB and Competent Authority, customizing the country budget, site budgets negotiation and contract signing, tracking and facilitating site compliance to required training, and.

Moscow, Russian Federation

• Responsible for all project management activities in preclinical and clinical studies required for Marketing Authorization of the company’s medicinal products in the Russian Federation: creation of the essential study.
• Responsible for keeping all clinical deliverables of the clinical studies within agreed timelines and budget;
• Keep high standards of quality in clinical trials and ensure that all activites are performed according to the company’s SOPs, working instructions and all applicable regulatory requirements;
• Participation in quality management system’s maintenance: SOPs’ creation / revision, participation in internal / external audits, CAPAs implementation.

Moscow, Russian Federation

• Responsible for all aspects of project management activities from the study initiation till the close-out for the assigned protocols;
• Feasibility work for new requests from the Sponsors or CRO;
• Preparing the essential documents for the study start;
• Negotiation and signing the study contract / budget with the Sponsors and CRO;
• Initial training of the CRA’s and site staff at the Investigators’ meeting;
• Ensuring all essential data are entered into Informational system of the Clinical trials on time;

Moscow, Russian Federation

09.2014 - 07.2015 - Clinical research associated II02.2012 - 09.2014 - Clinical research associated I09.2010 - 02.2012 - Clinical research assistant· Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors.

Moscow, Russian Federation

• conducting routine laboratory examination
• assuring quality of the analytical process
• carrying out scientific work

Specialist, Internship In Pharmaceutical Chemistry

Pharmacy